WO2006040882A1

WO2006040882A1 - Blood dialyzing apparatus

Info

Publication number: WO2006040882A1
Application number: PCT/JP2005/015741
Authority: WO
Inventors: Masahiro Toyoda; Yasushi Takakuwa
Original assignee: Nikkiso Company Limited
Priority date: 2004-10-15
Filing date: 2005-08-30
Publication date: 2006-04-20
Also published as: KR20070067134A; DE602005024846D1; JP2006110120A; EP1800703A1; EP1800703B1; EP1800703A4; TW200616682A; US20060081517A1; TWI418376B; KR101147499B1; US7537687B2; CN100528250C; CN1968723A; JP4260092B2

Abstract

[PROBLEMS] To provide a blood dialyzing apparatus capable of detecting removal of a puncture needle from a patient undergoing blood dialysis accurately by monitoring the potential difference at a predetermined portion while imparting a voltage to the blood flowing through a blood circuit, and capable of suppressing an increase of the manufacturing cost of a disposable blood circuit. [MEANS FOR SOLVING PROBLEMS] The blood dialyzing apparatus comprises an artery side blood circuit (1a) and a vein side blood circuit (1b), a blood pump (3), a dialyzer (2), a blood dialyzator body (6) having a dialysis liquid introduction line(L1) and a dialysis liquid discharge line (L2), a voltage imparting means (5), a potential detecting means (12), and a means (15) for monitoring removal of a puncture needle from a patient while referencing the potential detected by the detection means (12). The voltage imparting means (5) has one electrode (5a) interposed between an artery side puncture needle (a) in the artery side blood circuit (1a) and the blood pump (3), and the other electrode (5b) arranged in the dialysis liquid discharge line (L2).

Description

Specification

Hemodialysis machine

Technical field

The present invention relates to a blood permeation apparatus for performing dialysis treatment by purifying a patient's blood while circulating it extracorporeally.

Background art

[0002] In general, for dialysis treatment, a blood circuit having a flexible tube force for circulating a patient's blood extracorporeally is used. This blood circuit is mainly composed of an arterial blood circuit with an arterial puncture needle attached to the tip for collecting blood from a patient and a venous blood circuit with a venous puncture needle attached to the tip for returning blood to the patient. Thus, a dialyzer is interposed between the arterial blood circuit and the venous blood circuit to purify blood circulating outside the body.

[0003] A powerful dialyzer has a plurality of hollow fibers disposed therein, and blood passes through each hollow fiber, and the outside (the outer peripheral surface of the hollow fiber and the inner peripheral surface of the housing). In the meantime, the dialysate can flow. The hollow fiber has micropores (pores) formed in its wall surface to form a blood purification membrane. Blood waste that passes through the hollow fiber penetrates the blood purification membrane and passes through the blood purification membrane. In addition to being discharged into the body, waste blood is discharged and purified blood returns to the patient's body.

[0004] By the way, during dialysis treatment, when the puncture needle punctured by the patient falls off for some reason and the arterial puncture needle falls off the patient force, the arterial puncture needle force absorbs air and sucks air in the dialyzer. When there is a lock or when the venous puncture needle falls off the patient's force, there is a problem that the blood of the patient into which the arterial puncture needle force is introduced flows out without returning to the patient's body. The patient's blood pressure (venous pressure) flowing through the venous blood circuit that detects the drop of the puncture needle is monitored. That is, when the puncture needle is removed from the patient, the puncture needle is opened to the atmosphere, and the pressure of the blood flowing through the venous blood circuit is reduced. By detecting this, the removal of the puncture needle from the patient can be detected. . [0005] During dialysis treatment, however, the pressure (venous pressure) detected by the pressure sensor usually changes due to clogging of the dialyzer or changes in the blood state of the patient. Even if it is not abnormal, the venous pressure changes, so it is not possible to discriminate well whether the pressure change is due to a non-abnormal state such as a change in the patient's body position or due to an abnormality such as a drop in the venous puncture needle. There was a malfunction.

[0006] For this reason, for example, as disclosed in Patent Document 1, by applying a voltage between one electrode and the other electrode, voltage is applied to blood flowing through the blood circuit. Means (voltage generator in the same document), detection means (same detector) for detecting the potential associated with the voltage applied by the voltage applying means, and the detection values by these two detecting means are compared. There has been proposed a hemodialysis apparatus equipped with a monitoring means for obtaining a potential difference (same calculation means). In other words, when the puncture needle also loses the patient force, the detection means is arranged so that the potential difference required by the monitoring means fluctuates, and the puncture needle dropout can be effectively monitored based on the force fluctuation! /

Patent Document 1: Japanese Translation of Special Publication 2003-518413

Disclosure of the invention

Problems to be solved by the invention

[0007] However, the conventional hemodialysis apparatus has the following problems because one electrode and the other electrode of the voltage applying means are both disposed in the blood circuit. That is, since the blood circuit is a so-called disposable product that is discarded every dialysis treatment, if the blood circuit is provided with two electrodes, the blood circuit is discarded for every two electrodes at the end of treatment. There was a problem that the manufacturing cost increased accordingly. In addition, in the conventional hemodialysis apparatus described above, the wiring of the extracorporeal blood circuit is complicated, which may increase the work load of the staff to be attached or cause a wiring error.

[0008] The present invention has been made in view of such circumstances, and by monitoring the potential difference at a predetermined site while applying a voltage to the blood flowing through the blood circuit, the puncture needle of a patient force during hemodialysis treatment is provided. Provided is a hemodialysis apparatus that can accurately detect dropout and can suppress an increase in manufacturing cost of a blood circuit that is a disposable product. It is in.

Means for solving the problem

[0009] The invention according to claim 1 is a blood circuit comprising an arterial blood circuit and a venous blood circuit in which an arterial puncture needle and a venous puncture needle are attached to a distal end of the patient's blood that circulates outside the body. A blood pump disposed in the arterial blood circuit, a blood purification means connected between the arterial blood circuit and the venous blood circuit, for purifying blood flowing through the blood circuit, and the blood A dialysate main body having a dialysate introduction line and a dialysate discharge line for introducing and discharging dialysate to and from the purifying means, one electrode and the other electrode, and the blood circuit between these electrodes A voltage applying means for applying a voltage to blood flowing through the blood, a detecting means for detecting potentials at least at two locations associated with the voltage applied by the voltage applying means, and the respective potentials detected by the detecting means. To find the potential difference, In the hemodialysis apparatus comprising a monitoring means for monitoring the drop of patient force of the arterial puncture needle or the venous side puncture needle, one electrode of the voltage applying means is an artery in the arterial blood circuit. It is arranged between the side puncture needle and the blood pump, and the other electrode is arranged in the dialysate introduction line or dialysate discharge line.

[0010] The invention according to claim 2 is the hemodialysis apparatus according to claim 1, wherein at least one of the detection means detects a potential of one electrode or the other electrode of the voltage applying means. To do.

[0011] The invention according to claim 3 is the hemodialysis apparatus according to claim 1 or claim 2, wherein the voltage applying means or the detecting means is directly applied to blood or dialysate to apply a voltage or to apply a potential. It is what detects.

[0012] The invention according to claim 4 is the hemodialysis apparatus according to any one of claims 1 to 3, wherein the monitoring means uses the frequency component of the detection value detected by the detection means. A potential difference is obtained by extraction.

The invention's effect

[0013] According to the invention of claim 1, since the other electrode is disposed in the dialysate introduction line or the dialysate discharge line of the dialyzer body, a predetermined voltage is applied to the blood flowing through the blood circuit. Puncture of patient force during hemodialysis treatment by monitoring the potential difference at the site It is possible to accurately detect needle dropout and to suppress an increase in manufacturing cost of a disposable blood circuit.

[0014] According to the invention of claim 2, since at least one of the detection means detects the potential of one electrode or the other electrode of the voltage application means, the contact of the detection means and one of the potential application means The electrode or the other electrode can be shared, and an increase in manufacturing cost can be further suppressed.

[0015] According to the invention of claim 3, since the voltage applying means or the detecting means applies a voltage or detects a potential directly in contact with blood or dialysate, the voltage applied by the voltage applying means is very small. Even if it exists, the potential can be reliably detected by the detection means, and the drop of the puncture needle can be reliably monitored by the monitoring means.

[0016] According to the invention of claim 4, since the monitoring means extracts the frequency component of the detected value detected by the detecting means and obtains the potential difference, the voltage applied by the voltage applying means can be reduced, and the detection is performed. The detection accuracy by the means can be increased.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.

The hemodialysis apparatus according to the present embodiment performs dialysis treatment by purifying the patient's blood while circulating it extracorporeally. The powerful hemodialysis apparatus includes blood purification means as shown in FIG. The dialyzer main body 6 is mainly composed of a blood circuit 1 to which a dialyzer 2 is connected and a dialyzer 2 for removing water while supplying dialysate. As shown in the figure, the blood circuit 1 is mainly composed of an arterial blood circuit la and a venous blood circuit lb made of a flexible tube. The arterial blood circuit la and the venous blood circuit lb Dialer 2 is connected between.

[0018] An arterial puncture needle a is connected to the tip of the arterial blood circuit la, and an iron-type blood pump 3 is disposed in the middle, while a venous blood circuit lb has In addition, a venous puncture needle b is connected to the tip thereof, and a drip chamber 4 for defoaming is connected on the way.

[0019] Then, when the blood pump 3 is driven in a state where the patient has punctured the arterial puncture needle a and the venous puncture needle b, the blood of the patient passes through the arterial blood circuit la and reaches the dialyzer 2, Blood purification is performed by the dialyzer 2, and bubbles are removed in the drip chamber 4, and then returned to the patient's body through the venous blood circuit lb. That is, the patient's blood is purified by the dialyzer 2 while circulating outside the body through the blood circuit 1.

[0020] The dialyzer 2 is formed with a blood introduction port 2a, a blood outlet port 2b, a dialysate inlet port 2c, and a dialysate outlet port 2d in the casing, of which the blood inlet port 2a has an artery. The proximal end of the side blood circuit la is connected to the blood outlet port 2b, and the proximal end of the venous blood circuit lb is connected thereto. The dialysate introduction port 2c and the dialysate lead-out port 2d are connected to a dialysate introduction line L1 and a dialysate discharge line L2 extending from the dialyzer body 6, respectively.

[0021] A plurality of hollow fibers are housed in the dialyzer 2, the inside of the hollow fibers is used as a blood flow path, and dialysis is performed between the outer peripheral surface of the hollow fibers and the inner peripheral surface of the casing. It is used as a liquid flow path. A hollow fiber is formed in the hollow fiber by forming a number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface, and waste products in blood are dialyzed through the membrane. It is configured to be able to penetrate into the liquid.

[0022] Furthermore, one electrode 5a is formed between the arterial puncture needle a and the blood pump 3 in the arterial blood circuit la, and the other electrode 5b is formed on the dialysate introduction line L1, respectively. The electrodes are connected to a voltage applying means 5 for applying a voltage to the blood flowing through the blood circuit 1. When a voltage is applied by the voltage applying means 5, the blood pump 3 is partially blocked by the squeezing operation of the blood pump 3 at the location where the blood pump 3 is disposed, and thus the arterial puncture needle a Current flows through the blood and dialysate in the path between the one electrode 5a and the other electrode 5b including the venous puncture needle b.

That is, when a voltage is applied by the voltage applying means 5 during dialysis treatment, the arterial blood circuit la, the arterial puncture needle a, the patient's body, the venous puncture needle b, the venous blood circuit lb, and the dither With the blood flow path and the dialysate flow path of the riser 2 and the dialysate introduction line L1 as closed circuits, current flows through the blood and dialysate flowing inside each of them. Further, on the downstream side of the drip chamber 4 in the venous blood circuit lb (the venous puncture needle b side), a detecting means 12 for detecting the potential of blood flowing through the part is formed. In addition, Dairy The blood and dialysate are made conductive through the 2 membrane.

On the other hand, as shown in FIG. 2, the dialysis machine main body 6 includes a dual pump 11 formed across the dialysate introduction line L1 and the dialysate discharge line L2, and a dual pump 11 in the dialysate discharge line L2. Is mainly composed of a Binos line L3 connected around the line and a dewatering pump 8 connected to the bypass line L3. Then, one end of the dialysate introduction line L1 is connected to the dialyzer 2 (dialyte introduction port 2c), and the other end is connected to the dialysate supply device 7 for preparing a dialysate having a predetermined concentration.

[0025] One end of the dialysate discharge line L2 is connected to the dialyzer 2 (dialysate outlet port 2d), and the other end is connected to a waste fluid means (not shown). The dialysate supplied from 1 reaches the dialyzer 2 through the dialysate introduction line L1, and then is sent to the waste fluid means through the dialysate discharge line L2 and the bypass line L3. In the figure, reference numerals 9 and 10 denote a heater and a deaeration means connected to the dialysate introduction line L1.

[0026] The water removal pump 8 is for removing blood and moisture of the patient flowing through the dialyzer 2. That is, when the powerful dewatering pump 8 is driven, since the duplex pump 11 is a fixed type, the volume of the liquid discharged from the dialysate discharge line L2 is larger than the amount of dialysate introduced from the dialysate introduction line L1. As the volume increases, water is removed from the blood by that much volume. It should be noted that the blood force of the patient may be removed by means other than the powerful water removal pump 8 (for example, using a so-called balancing chamber).

[0027] Here, a monitoring means 15 comprising a potential difference calculating means 13 and a comparing means 14 is disposed in the dialyzer body 6, and the potential difference calculating means 13 is connected to the other via wirings HI and H2. The electrode 5b and the detection means 12 are connected to each other. However, in the other electrode 5b, the potential of that part is detected (it is known in this embodiment), and the potential is sent to the potential difference calculating means 13. That is, the other electrode 5b has both the electrode of the voltage application means 5 and the contact as the detection means, and is shared, and the manufacturing cost of the blood circuit 1 is lower than that having two detection means without sharing. The increase can be suppressed.

[0028] It should be noted that the voltage applying means 5 according to the present embodiment has an AC power supply, and therefore the other electrode 5b and The detected value of the detecting means 12 is converted to a direct current by a smoothing circuit in the potential difference calculating means 13 so that the potential difference between the two parts is obtained. Then, the obtained potential difference is sent to the comparison means 14. Compared to the reference value (potential difference when the arterial puncture needle a and the venous puncture needle b are normally punctured and normal treatment is performed), the comparing means 14 that works is changed. In this case, the alarm means 16 gives an alarm if any of the puncture needles falls out of the patient force.

[0029] Specifically, in a state where the arterial puncture needle a and the venous puncture needle b are normally punctured to the patient, blood in a closed circuit including both the puncture needles a and b as described above. In the meantime, a potential difference substantially equal to the reference value is detected, and if any of the puncture needles loses the patient force, the circuit is interrupted and no current flows, so the detected potential difference decreases. It approaches. By monitoring the change in the potential difference applied, the monitoring means 15 can detect the drop of the arterial puncture needle a or the venous side puncture needle b as much as possible.

[0030] The alarm means 16 is for urging attention to surrounding medical staff when the monitoring means 15 determines that the arterial puncture needle a or the venous puncture needle b has been detached from the patient. It is configured to warn by the occurrence of a predetermined sound due to the force of the sound, the flashing or lighting of a warning light, or display on the display unit (all not shown). If the monitoring means 15 changes the potential difference significantly from the reference value, measures such as stopping the dialysis treatment such as stopping the blood pump 3 in conjunction with or in place of the alarm by the alarm means 16 are taken. You may do it.

[0031] Furthermore, the contact points of the one electrode 5a, the other electrode 5b, and the detection means 12 of the voltage applying means 5 are directly connected to blood flowing in the arterial blood circuit la or dialysate flowing in the dialysate introduction line L1. It is configured to apply a voltage or detect a potential in contact. For example, a T-shaped tube is connected to a portion where these electrodes and contacts are disposed, and the electrodes and contacts are inserted through the T-tube to be covered so as to face the blood or dialysate flow path. I like it. Thereby, even if the voltage applied by the voltage applying means 5 is very small, the potential can be reliably detected by the detecting means 12 and the other electrode 5b, and the puncture needle a or b can be detected by the monitoring means 15. Can be reliably monitored.

[0032] According to the above-described embodiment, a predetermined voltage is applied to blood and dialysate during dialysis treatment. By monitoring the potential difference at the site, it is possible to accurately detect the dropout of the puncture needles a and b of the patient force, and the other electrode 5b is disposed in the dialysate introduction line L1 of the dialyzer body 6. Therefore, it is possible to suppress an increase in the manufacturing cost of the blood circuit 1 which is a disposable product.

As described above, the force described in the present embodiment is not limited to this. For example, the configurations shown in FIGS. 3 to 5 may be adopted. That is, in FIG. 3, one electrode 5a is disposed between the arterial puncture needle a and the blood pump 3 in the arterial blood circuit la, and the other electrode 5b is connected to the dialysate introduction line L1. The detecting means 12a and 12b that are arranged and detect the potential associated with the voltage applied by the voltage applying means 5 are respectively formed downstream of the dripping chamber 4 in the venous blood circuit lb (venous puncture needle b side). In FIG. 4, the one electrode 5a, the other electrode 5b, and the detection means 12a are arranged in the same manner, but the detection means 12b is located upstream of the one electrode 5a in the arterial blood circuit la. (Arterial puncture needle a side).

[0034] According to these other embodiments as well, the potential difference detected by the detection means 12a and 12b when the arterial puncture needle a or the venous puncture needle b falls off during the dialysis treatment is also used as a reference. (The potential difference decreases in Fig. 3 and the potential difference increases in Fig. 4). Therefore, the potential difference at a given site should be monitored while applying voltage to blood and dialysate during dialysis treatment. This makes it possible to accurately detect the puncture needles a and b with patient force, and the other electrode 5b is disposed on the dialysate introduction line L1 of the dialyzer body 6 and is a disposable product. An increase in the manufacturing cost of blood circuit 1 can be suppressed.

[0035] Further, what is shown in FIG. 5 is that two detection means 12a and 12b are disposed on a wiring extending from the voltage applying means 5 to the other electrode 5b, and impedance equivalent to blood flowing through the blood circuit 1 is provided. A resistor R is provided. The dialysis needle can be monitored for removal of the puncture needle due to the potential difference detected by the detection means 12a and 12b even with a hemodialysis apparatus. In addition to the other electrode 5b of the voltage application means 5, the detection means 12a and 12b Therefore, the increase in the manufacturing cost of the blood circuit 1 which is a disposable product can be further suppressed.

In the present embodiment, the detected value detected by the detecting means is used as the potential difference calculating means 1 Instead of this, it is possible to extract the frequency component of the detected value by frequency analysis, bandpass filter, etc., and monitor the change in potential difference by monitoring the intensity of that component. According to the configuration that makes it easy, the voltage applied by the voltage applying means can be reduced, and the detection accuracy by the detecting means can be increased.

[0037] It should be noted that a direct current may be applied instead of the voltage applying means comprising an alternating current power supply. The electrode of the voltage applying means or the contact of the detecting means is replaced with a liquid contact type (directly in contact with blood or dialysate) as described above, and capacitive coupling (a conductive material is disposed around the blood circuit). Indirect application of voltage) may also be used. However, the voltage application by the voltage applying means as described above may be performed continuously throughout the dialysis treatment or may be performed intermittently. When voltage is applied intermittently, it can be expected that the patient's anxiety associated with voltage application can be suppressed.

[0038] In the present embodiment, the other electrode 5b is arranged in the dialysate introduction line L1, but it may be arranged in the dialysate discharge line L2 instead. In FIG. 1, one of the electrodes and the detection means are shared, but the other electrode and the detection means may be shared. Furthermore, in this embodiment, the dialysis machine body 6 is composed of a dialysis monitoring device that does not have a dialysate supply mechanism, but is applied to a personal dialyzer with a dialysate supply mechanism. Also good.

Industrial applicability

[0039] One electrode of the voltage applying means is disposed between the arterial puncture needle and the blood pump in the arterial blood circuit, and the other electrode is disposed on the dialysate introduction line or the dialysate discharge line. The installed hemodialysis apparatus can be applied even if it has a different appearance or has other functions.

Brief Description of Drawings

FIG. 1 is a schematic diagram showing a hemodialysis apparatus according to an embodiment of the present invention.

FIG. 2 is a schematic diagram showing the main body of the dialysis machine in the hemodialysis machine

FIG. 3 is a schematic view showing a hemodialysis apparatus according to another embodiment of the present invention.

FIG. 4 is a schematic view showing a hemodialysis apparatus according to another embodiment of the present invention.

FIG. 5 is a schematic view showing a hemodialysis apparatus according to another embodiment of the present invention. Explanation of symbols

1 Blood circuit

la Arterial blood circuit

lb venous blood circuit

2 Dializer (means for blood purification)

3 Blood pump

4 Drip chamber

5 Voltage application means

5a One electrode

5b The other electrode

6 Dialysis machine body

7 Dialysate supply device

8 Water removal pump

9 Heater

10 Degassing means

11 Double pump

12 Detection means (Contact)

13 Potential difference calculation means

14 Comparison means

15 Monitoring means

16 Alarm means

a Arterial puncture needle

b Venous puncture needle

Claims

The scope of the claims

[1] a blood circuit composed of an arterial blood circuit and a venous blood circuit with an arterial puncture needle and a venous puncture needle attached to the tip of the patient's blood circulating outside the body;

A blood pump disposed in the arterial blood circuit;

Blood purification means connected between the arterial blood circuit and the venous blood circuit and purifying blood flowing through the blood circuit;

A dialyzer body having a dialysate introduction line and a filtrate discharge line for introducing and discharging dialysate to and from the blood purification means;

A voltage applying means having one electrode and the other electrode, and applying a voltage to the blood flowing between the electrodes in the blood circuit;

Detecting means for detecting at least two potentials associated with the voltage applied by the voltage applying means;

Monitoring means for comparing the respective potentials detected by the detection means to determine a potential difference and monitoring a drop in patient force of the arterial puncture needle or vein side puncture needle;

A hemodialysis machine equipped with

One electrode of the voltage applying means is disposed between the arterial puncture needle and the blood pump in the arterial blood circuit, and the other electrode is connected to the dialysate introduction line or the dialysate discharge line. A hemodialysis apparatus characterized by being disposed.

2. The hemodialysis apparatus according to claim 1, wherein at least one of the detection means detects a potential of one electrode or the other electrode in the voltage application means.

[3] The hemodialysis apparatus according to [1] or [2], wherein the voltage applying means or the detecting means applies a voltage or detects a potential in direct contact with blood or dialysate. .

[4] The blood according to any one of claims 1 to 3, wherein the monitoring unit obtains a potential difference by extracting a frequency component of a detection value detected by the detection unit. Permeation device.